Background: The care of venous thromboembolism (VTE) is currently undergoing a paradigm shift in the US with an increasingly large percentage of patients being discharged home from the Emergency Department (ED). It wasn’t too long ago that all patients diagnosed with deep vein thrombosis (DVT) and pulmonary embolism (PE) would be admitted for anticoagulation. Some of the reasons for this were lack of literature to support outpatient therapy in the US, inability to arrange outpatient follow up, and, of course, medicolegal concerns. Dr. Jeff Kline, one of the thought leaders in VTE, advocates for the outpatient treatment of “low-risk” patients using a modified Hestia criteria supplemented with additional criteria (POMPE-C) for patients with active cancer. This publication is the initial results of his rivaroxaban-based treatment protocol.

What They Did:

Development of a Rivaroxaban based protocol to predict which patients are safe for outpatient treatment, diagnosed with DVT or PE

1mg/kg Enoxaparin SQ and one 15mg rivaroxaban dose by mouth prior to discharge

Patients then took 15mg PO BID for 21 days followed by 20mg PO QD of Rivaroxaban until therapy completed

Prospective observational study at two US hospitals

Outcomes:

Acceptable outcomes were defined as:

Venous thromboembolism (VTE) recurrence ≤2.1%

Bleeding ≤9.4%

A pooled analysis of the EINSTEIN DVT and PE trials was used to determine these numbers

Definitions:

Major bleeding: >2g/dL acute drop in hemoglobin or >2-unit blood transfusion, bleeding in a critical area, or bleeding that contributed to death

Clinically Relevant Non-Major Bleeding: Bleeding that requires the patient to make an unscheduled visit to any health care provider for evaluation, permanently discontinue rivaroxaban, or significantly alter activities of daily living for more than a few days

Inclusion:

Low Risk patients were identified using a Modified Hestia Criteria and the POMPE-C tool in patients with active malignancy

Modified Hestia Exclusion Criteria:

Systolic Hypotension (<100mmHg in absence of history of low blood pressure at baseline)

Author Conclusion: “Patients diagnosed with VTE and immediately discharged from the ED while treated with rivaroxaban had a low rate of VTE recurrence and bleeding.”

Clinical Take Home Point: This is a nice proof of concept publication that further adds to the evidence for the safety of outpatient treatment of low risk DVT and PE in patients with very low complication rates.